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Healthcare › Data Collection › Medical Devices

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

Jones Day on

The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

McDermott+

Inpatient Prospective Payment System (IPPS) Data Dashboard

McDermott+ on

Updated to include Medicare claims data thru Q3 2024. What is the cost of a knee implant in the inpatient setting? How much does Medicare pay for different types of cardiac valve procedures? How have Medicare inpatient...more

Dickinson Wright

Part 3: Key Takeaways from Claim Examples in the 2024 AI Patent Eligibility Guidance

Dickinson Wright on

This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more

Akin Gump Strauss Hauer & Feld LLP

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

Akin Gump Strauss Hauer & Feld LLP on

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more

Gardner Law

Navigating the Complex Regulatory Landscape for AI/ML-Enabled Medical Devices

Gardner Law on

The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the healthcare industry. However, as these innovative devices emerge, understanding the complex regulatory landscape becomes...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

Butler Snow LLP on

Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

Epstein Becker & Green on

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

McDermott Will & Emery

Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

McDermott Will & Emery on

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more

Holland & Knight LLP

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

Faegre Drinker Biddle & Reath LLP

Fitbit Agrees to Sign Business Associate Agreements and Take on HIPAA Compliance

Faegre Drinker Biddle & Reath LLP on

Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more

Buchalter

Delivering Health Care Services to Consumers through eHealth Devices: The Role of State Professional Practice Laws

Buchalter on

Smart medical devices that can deliver health care services are increasingly consumer friendly. Using the latest technologies and sophisticated algorithms, some devices are capable of collecting data directly from consumers...more

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